Anavex Life Sciences Q1 2026 Earnings Call - Blarcamesine heads into EMA re-examination after CHMP negative opinion, FDA Type C feedback and ACCESS-AD tie‑in

Clint Tomlinson, Conference Call Host, Anavex Life Sciences: Good morning, everyone, and welcome to the Anavex Life Sciences Fiscal 2026 First Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today’s call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session, and during this session if you would like to ask a question please use the Q&A box or raise your hand. Please note this conference is being recorded and the call will be available on Anavex’s website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer, and Sandra Boenisch, Principal Financial Officer. Before we begin, please note that during this conference call the company will make some projections and forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties.

We encourage you to review the company’s filings with the SEC, and this includes, without limitation, the company’s Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. This conference call discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such products will successfully complete clinical development or gain health authority approval. With that, I would like to turn the call over to Dr. Missling.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our First Quarter Financial Results and Quarterly Business Update. As we enter 2026, we continue to progress our innovative clinical pipeline with particular focus on our lead candidate, oral blarcamesine, in early Alzheimer’s disease. Based on our commitment to improving the lives of patients with neurological disorders, we remain excited about the therapeutic potential of oral blarcamesine. We look forward to working with the regulatory agencies in Europe and in the U.S. to advance blarcamesine as a potential new treatment option for patients. We recently announced Anavex’s participation as a key industry partner in ACCESS-AD, a major new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer’s disease across real-world clinical settings.

The multi-year program is funded by the European Commission’s Innovative Health Initiative and unites leading academic centers, technology developers, industry innovators, and patient organizations to strengthen equitable access to timely and effective Alzheimer’s disease care. As part of the consortium, blarcamesine will be evaluated in a clinical prediction study. As an update to our regulatory pathway, in January we announced feedback from an FDA Type C meeting, in which the FDA shared their feedback to Anavex’s development plans. The meeting discussed the potential pathways to support blarcamesine for Alzheimer’s disease. In order to move forward, it is expected that existing data from the Phase IIB/III Anavex 2-73-AD-004 program will be submitted to the FDA. In December, as expected, the CHMP adopted a negative opinion on the marketing authorization application for blarcamesine. Subsequently, on December 18, Anavex announced it had requested the EMA to re-examine its opinion.

We are working closely with the EMA during this process, which is being led by a different rapporteur and co-rapporteur. In November, we announced presentations at the 18th CTAD Conference in San Diego. The oral late-breaking communication oral blarcamesine Phase IIb/III trial confirms identified precision medicine patient population, significant broad clinical and quality-of-life improvements for early Alzheimer’s disease patients, and two posters’ presentations featuring blarcamesine. Looking forward, we will provide both regulatory and clinical trial updates on blarcamesine in other indications such as Parkinson’s disease and fragile X syndrome. This will include disclosure of planned future clinical trial designs as we continue to advance our therapeutic pipeline. Additionally, new scientific findings will be presented at upcoming conferences or in upcoming publications.

An oral presentation at the 16th Intrinsic Capacity Frailty and Sarcopenia Research Conference for Healthy Longevity to be held March 10 to 12 at Johns Hopkins University Bloomberg Center in Washington, D.C. The new findings on a clinical relationship with a biomarker, correlation between clinical endpoints, and reduced brain region atrophy with blarcamesine in early Alzheimer’s disease. A publication on Alzheimer’s disease regarding precision medicine Aβ-Clear patient populations of the Anavex 2-73 AD-004 Phase IIb/III trial. Another publication on Alzheimer’s disease on the precision medicine gene COL24A1, which with an estimated over 70% prevalence in the early Alzheimer’s disease population, which has the potential to establish effective treatment of early Alzheimer’s disease through effectiveness of autophagy-enhancing blarcamesine. A publication regarding Fragile X Syndrome, blarcamesine corrects EEG biomarkers of cortical dysfunction in a mouse model of Fragile X Syndrome.

With regard to Anavex 3-71, we will be advancing Anavex 3-71 towards pivotal clinical studies for the treatment of schizophrenia-related disorders. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for a financial summary of the recently reported quarter.

Sandra Boenisch, Principal Financial Officer, Anavex Life Sciences: Thanks, Christopher. Good morning to everyone. I am pleased to share with you today our First Quarter Financial Results. Our cash position at December 31st was $131.7 million with no debt. During the quarter, we utilized cash and cash equivalents of $7.1 million in operating activities after taking into account changes in non-cash working capital accounts. As of today, we anticipate that at the current cash utilization rate, our cash runway is more than three years. Our research and development expenses for the quarter were $4.7 million as compared to $10.4 million for the comparable quarter of last year. General and administrative expenses were $2.1 million as compared to $3.1 million for the comparable quarter of last year.

Compared to the same quarter of Fiscal 2025, we saw a decrease in operating expenses, mostly driven by the completion of a large manufacturing campaign of blarcamesine conducted in Fiscal 2025, and a decrease in clinical trial activities as a result of the completion of our Anavex 3-71 phase II study in schizophrenia. And lastly, we reported a net loss of $5.7 million for the quarter, or $0.06 per share. Thanks, and I’ll turn it back to you, Christopher.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Thank you, Sandra. In summary, we have focused on continuing to advance the development of our precision medicine compounds. We are excited to be potentially making a difference to individuals suffering from neurological diseases by presenting scalable treatment options alongside the ease of oral administration. I would now like to turn the call back to Clint for Q&A.

Clint Tomlinson, Conference Call Host, Anavex Life Sciences: Thank you, Christopher. We will now begin the Q&A session. If you have a question, please raise your hand or enter it in the Q&A box. Our first question will come from Ram Selvaraju from H.C. Wainwright. You should be connected now, Ram. But I see you muted.

Ram Selvaraju, Analyst, H.C. Wainwright: Hello, can you hear me?

Clint Tomlinson, Conference Call Host, Anavex Life Sciences: Yes.

Ram Selvaraju, Analyst, H.C. Wainwright: Thanks so much for taking our questions. Firstly, I was wondering if you could, at this juncture, provide us with some additional information regarding who the rapporteur and co-rapporteur are for the re-examination of the CHMP opinion on blarcamesine.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: The 27 countries of the EU decide on two rapporteurs. It is one of the two countries of the 27 will be the rapporteurs.

Ram Selvaraju, Analyst, H.C. Wainwright: Okay. Can you provide us with additional information regarding the timeline with which the re-examination is likely to occur? My understanding is that in effect it starts at noon o’clock, but that this might be as short as six months. Can you confirm that?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: That is correct. It is a 60 + 60-day period where we respond to the re-examination request, and then the review by the two rapporteurs will take another 60 days. That’s why we stated that we expect this process to last for the first half of this year.

Ram Selvaraju, Analyst, H.C. Wainwright: Can you provide a timeline regarding when you anticipate potentially filing formal NDA submission with the FDA?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: This is a plan we will advance once we are getting closer, but the last meeting was very productive we had with the FDA, and so we continue with this request which we were giving that we will provide the full data package to the FDA for addressing their review and expecting next steps from there.

Ram Selvaraju, Analyst, H.C. Wainwright: Can you just remind us what type of meeting this was that you held with the FDA, the most recent one?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: There was a Type C Meeting.

Ram Selvaraju, Analyst, H.C. Wainwright: Okay, thank you.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Thank you.

Clint Tomlinson, Conference Call Host, Anavex Life Sciences: Thank you, Ram. Next question comes from Tom Bishop of BI Research. Tom, you should be on now.

Tom Bishop, Analyst, BI Research: Can you hear me?

Clint Tomlinson, Conference Call Host, Anavex Life Sciences: Yes, go ahead.

Tom Bishop, Analyst, BI Research: Can you go into a little bit more detail about what additional information will be in the resubmission to the EMA, in terms of will Aβ-Clear data be in there, brain volume data, COL24A1, and OLE? Can you just give us a little bit more meat on the bone?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: That’s, that’s absolutely possible. So for background, in the resubmission, we are able to address and provide feedback on the arguments why this drug should be re-examined for approval for EMA review, and as a reminder that there is a requirement for granting conditional approval for if the disease is serious, if there’s a major unmet need, if the data shows clinically meaningful effects, if there’s a strong mechanistic rationale, especially linking genetic variants, and is there supporting evidence from translational data available. And the sponsor is then also committing to a study in executing it and confirming the efficacy during the approval during the approved process. And we are including the data of the AD-004 study, the open-label open-label study, the data on the Aβ-Clear study population, as well as the correlation of the efficacy of the clinical efficacy with the brain atrophy reduction.

Tom Bishop, Analyst, BI Research: Now, was none of that actually in the, you know, those last few that you mentioned in the original submission such that this could potentially be more persuasive as it is for me?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Yeah, it’s really like a process, I would say, and we also understand that is something which a counterparty has to digest, and maybe that is the reason also we’ve seen now in the past several cases where even with drugs which were prior approved already, and with very large companies submitting those, you know, trial data we ended up at the same situation where we ended up today as well. But we can, of course, not guarantee the approval in this re-examination procedure, but it seems to be a question how to repackage or re-articulate the strength of the package or of the data.

Tom Bishop, Analyst, BI Research: Okay, and with the FDA, I know the question was asked when might you file this data with the FDA? I mean, it kind of already exists, so I’m, I was just wondering if you can be any more clear about why, we can’t they can’t why you can’t get that data to the FDA very soon.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: It’s in process, and you have to also understand the FDA has a certain meeting request which requires some time to schedule, and this is in the process as well, so that’s why it’s not like you just ship something over and then you get feedback, so you have to make it in consistency with a meeting request, and that’s what will happen.

Tom Bishop, Analyst, BI Research: Okay, are there any? Correct me if I’m getting the sense wrong here, but are there any trials currently in progress?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: The only trial we have ongoing is right now the compassionate use program for Rett Syndrome in three countries in three continents, in Canada, in U.K., in Australia, and we have also the compassionate use ongoing for Alzheimer’s Disease. We are planning now the studies in Parkinson’s Disease, in Fragile X Syndrome, and another indication which is not disclosed yet, and we also will proceed with the Alzheimer’s trial, which I mentioned before.

Tom Bishop, Analyst, BI Research: Okay, well, it’s been a little while since the Rett trial was finished, the Parkinson’s trial was finished several years now, and I’m just wondering if you can give us any near-term timeline for some of these additional schizophrenia, just wrapped up, the first trial.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Yeah, and.

Tom Bishop, Analyst, BI Research: As to when, so we’ll get something in this clinic.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Yeah, yeah, absolutely good question. We also plan a schizophrenia program to continue, as I mentioned this morning, so we are really gonna be very busy with trials, and we are very excited about it, and just to let you know the Parkinson’s disease trial has not been started yet, it was Parkinson’s disease dementia, but it’s the basis of which we are executing the Parkinson’s disease trial.

Tom Bishop, Analyst, BI Research: Okay, I guess that’s it from me for now.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Thank you.

Clint Tomlinson, Conference Call Host, Anavex Life Sciences: Hey, Tom. The next question will come from Jesse Silvera from Spirit of the Coast Analytics. You can go ahead, Jesse.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: All right, can you hear me all right?

Clint Tomlinson, Conference Call Host, Anavex Life Sciences: Yes, thank you.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: All right, good morning. This is Jesse Silvera with Spirit of the Coast Analytics. Thank you for taking my questions today. Before we get into some of my, I guess, more elaborate questions, maybe we can start with some quicker pitches. First up, something a lot of people have been kind of scratching their heads on is, clarity for CHMP rejection. In particular, we know that blarcamesine works better for patients with SIGMAR1 wild type. As a part of the CHMP rejection, the agency stated, and I quote, "The main study failed to demonstrate effectiveness and safety of blarcamesine (Anavex) in patients with early Alzheimer’s disease who do not have a mutation in the SIGMAR1 gene." End quote.

So this statement appears contrary to the facts because the drug is effective for patients who do not have a mutation in the SIGMAR1 gene, also known as SIGMAR1 wild type. So is it the company’s opinion that the CHMP made an error in how they phrased their rejection, or can you clarify the company’s understanding of this statement in particular?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Yeah, we would not criticize the regulatory bodies, but we would say that in consistency with our interpretation of the trial, we met the ADAS-Cog13, and there was more significant in the wild type SIGMAR1 population, as well as in the CDR-SB, which also was superior to the, I in the wild type compared to the ITT population. The ADL, ADCS-ADL endpoint, was the only one which was not significant, although it was trending positively, and as we and the academic world found out that this scale is not sensitive enough to pick up the changes of activities of daily living in 48 weeks in an early Alzheimer’s disease population. So that is the maybe the only difference in interpretation of the trial that that was, maybe differently evaluated.

But now when you go to the Aβ-Clear 3 population, you will see, and we submitted that, for publication, it’s already publicly available in a preprint, that the Aβ-Clear 3 population, which includes SIGMAR1 wild type, carriers with the COL24A1 wild type, gene, that those four patients have, significance reach significance across the board. So for ADAS-Cog13, for ADCS-ADL, and for CDR-SB, and they’re not only achieving significance, but they also achieve this with highly clinically meaningful effect sizes, which are sometimes 2-3 times larger than, what we have seen, so far from other compounds in the pipeline or on the market. So that’s kind of like why, this is intriguing now to also point that out and, and have that discussion and put that forward.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: Okay, thank you for that. And I’m kind of gonna I’m gonna skip around a minute just because you kind of led into it. So you stated in your Borrell Capital interview with Jason a few weeks ago that the re-examination would be under a CMA path and not a full Marketing Authorization. And in that interview, you explained that ADCS-ADL, one of your co-primary endpoints, had been invalidated as a reliable measure during your trial analysis phase due to a lack of sensitivity found within the community despite its previous status as the gold standard in Alzheimer’s trials. You then went into detail about new statistical methodology that the company was looking to use featuring a higher p-value threshold of 0.0167. And I know that the company has met ADAS-Cog13 and CDR-SB across all genetic cohorts with this p-value, or better.

The question is, does using this new threshold allow the company to circumnavigate the ADCS-ADL miss, and will regulators, ex in your view, accept the scientific invalidation of ADCS-ADL combined with your new gatekeeping strategy? If you can give any on that.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Yeah, as I just stated, this is exactly the discussion, which is probably ongoing if this ADL is identified clearly as not valid anymore, and if you follow science, you would agree with that because it’s an endpoint which has been earmarked as being useful for overt Alzheimer’s, for moderate and severe Alzheimer’s, but not sensitive enough for the early Alzheimer’s population, and that was confirmed actually in guidances from the regulatory bodies. So you would assume that that is a fair argument to have, and we stated that argument and make that argument as well.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: Okay, thank you for that. With that said, you went over the 60 + 60 day timeline earlier for this re-evaluation. We should be, I believe, near 60 days now. Have you already submitted the new strategy and package to the CHMP, and has a SAG been appointed yet?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: We will update everybody once we have the result of this process. We will not comment on the ongoing process, but the SAG will be part of the review process since we requested that, and we will expect this to be given to us, a dialogue involving the SAG, the scientific advisory group from the EMA for the neurology team.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: Okay, thank you. If I have it correct, you have committed to running a confirmatory phase for a trial if approved for CMA using paying patients as a real-world cohort. Isn’t that correct?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Sorry, what patients?

Jesse Silvera, Analyst, Spirit of the Coast Analytics: like paying patients in the EU. Assuming you are actually approved under CMA, will you be running a phase 4 trial with these patients?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: We will run.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: Or how would that look, I guess?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Yeah, we would run a trial as the regulatory body, the CHMP guidelines, provides for that you get approved, and then in parallel, you will run a confirmatory study. Yes.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: Okay, and I think relevant to additional Alzheimer’s trials is on 28 January of this year, Alzheimer’s Europe launched the Prevalence of Dementia in Europe 2025 report, which projected a 64% surge in dementia across Europe by 2050. Based on our research, it appears that Europe is not on course to meet projected health strategies, especially those centered on dementia, and it looks like they’re kind of as the EU moving away from social work and dementia in favor of defense and economy. So in light of these statements, it’s our understanding that Anavex is set to participate in ACCESS-AD, funded by the European Commission. Can you please give more detail on how blarcamesine, a currently unapproved drug, is to be involved in this program? Like, is the company running this trial? What are endpoints and objectives of this trial?

When will the first patient be dosed, or anything else you’d like to offer?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: The ACCESS-AD program is really a great opportunity for acknowledging Anavex as a participant and being part of the ecosystem in Europe for Alzheimer’s disease, which involves both academic institutions as well as government entities and advocacy groups within Europe. So we’re very pleased and excited about being part of that. A specific carve-out or not carve-out, especially part of this very large grant, if you like, is a dedicated clinical trial of blarcamesine as a placebo-controlled trial to look for data of prediction of the effect of blarcamesine in Alzheimer’s patients, in early Alzheimer’s patients, and that involves review of biomarkers and novel biomarkers, looking at autophagy signals and also including efficacy. And we’re planning to use this trial also for a regulatory specific goal. So we will make this trial part of our package for confirming the efficacy of blarcamesine in early Alzheimer’s disease.

So it’s a very intriguing project to be part of, and the ACCESS-AD program consists of multiple features. Among them is also a review of healthy diet, also a supplement diet is part of that, and they’re all separate, they’re not together, and as I just mentioned, one part is explicitly a trial of blarcamesine in a placebo-controlled clinical trial.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: Sorry if you mentioned, is this in early Alzheimer’s patients or is there like a preventative component to this trial?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Yeah, so it’s a good question. It could end up being a preventative also, but right now it’s consistent with an early Alzheimer’s population as a target population.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: Okay, and this would be considered AD006 on your pipeline chart, is that correct?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: That’s correct, yes. That would be AD006.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: Okay, great. I think I’m finishing up here. Is the autophagy to clinical improvement analysis or paper complete, and maybe if you could give any expectations on when we could get eyes on that?

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Yeah, so we have submitted now three papers which I mentioned this morning, and the atrophy paper is still not submitted but will be submitted soon as well.

Jesse Silvera, Analyst, Spirit of the Coast Analytics: Okay, great. And, okay, that’s pretty much all I have. Kudos on your JPM presentation and the new website format. They look great. And, it’s striking how little to lose, I think, the CHMP has by granting a MAA considerably considering this, you know, the sound clinical safety and efficacy of the drug on cognition, objective brain atrophy markers, and not to mention patient-assessed improvements measured by the quality of life AD survey. Yeah, so we have no further questions, and thank you again for having us.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: We appreciate that. Thank you.

Sandra Boenisch, Principal Financial Officer, Anavex Life Sciences: Thank you, Jesse. Dr. Missling, we have no more questions at this time.

Dr. Christopher Missling, President and Chief Executive Officer, Anavex Life Sciences: Thank you. So in closing, we continue to focus on execution as we advance our therapeutic pipeline to potentially improve patients’ lives living with these devastating conditions. We’re energized by the possibility of making a meaningful impact for people living with neurological diseases, offering treatment options that are not only scalable but also far easier to administer through an oral route. By lowering barriers to access and simplifying delivery, we hope to bring innovative therapeutics to a broader population and improve quality of life in a tangible way. Thank you.

Sandra Boenisch, Principal Financial Officer, Anavex Life Sciences: Thank you, ladies and gentlemen, for participating in the call today. We appreciate it, and this will conclude the conference. You may now disconnect.